Item 1. Financial Statements
Item
1. Financial Statements
HARROW
HEALTH, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share data)
June 30,
December 31,
2021
2020
(unaudited)
ASSETS
Current assets
Cash and cash equivalents, including restricted cash of $ 200
$ 72,851
$ 4,301
Investment in Eton Pharmaceuticals
12,209
28,455
Accounts receivable, net
3,710
2,662
Inventories
3,903
3,962
Prepaid expenses and other current assets
801
751
Total current assets
93,474
40,131
Property, plant and equipment, net
4,937
4,453
Operating lease right-of-use assets
4,747
6,799
Intangible assets, net
1,882
1,939
Investment in Surface Ophthalmics
-
1,314
Investment in Melt Pharmaceuticals
1,594
2,506
Investments
-
-
Goodwill
332
332
TOTAL ASSETS
$ 106,966
$ 57,474
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued expenses
$ 5,207
$ 3,932
Accrued payroll and related liabilities
2,388
2,315
Deferred revenue and customer deposits
56
66
Current portion of paycheck protection program loan payable
-
1,259
Current portion of loan payable, net of unamortized debt discount
-
2,639
Current portion of operating lease liabilities
485
580
Current portion of finance lease obligations
8
8
Total current liabilities
8,144
10,799
Operating lease liabilities, net of current portion
4,695
6,652
Finance lease obligations
14
17
Accrued expenses, net of current portion
-
800
Paycheck protection program loan payable, net of current portion
-
708
Loan payable, net of current portion and unamortized debt discount
71,265
11,670
TOTAL LIABILITIES
84,118
30,646
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 50,000,000 shares authorized, 26,893,896 and 25,749,875 shares issued
and outstanding at June 30, 2021 and December 31, 2020, respectively
27
26
Additional paid-in capital
102,837
104,557
Accumulated deficit
( 79,661 )
( 77,400 )
TOTAL HARROW HEALTH STOCKHOLDERS’ EQUITY
23,203
27,183
Noncontrolling interests
( 355 )
( 355 )
TOTAL EQUITY
22,848
26,828
TOTAL LIABILITIES AND EQUITY
$ 106,966
$ 57,474
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
3
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except for share and per share data)
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Revenues:
Sales, net
$ 17,297
$ 8,049
$ 32,245
$ 19,859
Other revenues
837
11
1,332
18
Total revenues
18,134
8,060
33,577
19,877
Cost of sales
( 4,417 )
( 3,204 )
( 8,187 )
( 6,830 )
Gross profit
13,717
4,856
25,390
13,047
Operating expenses:
Selling, general and administrative
9,123
6,954
17,287
15,370
Research and development
425
749
1,017
1,152
Impairment of intangible assets
-
363
-
363
Total operating expenses
9,548
8,066
18,304
16,885
Income (loss) from operations
4,169
( 3,210 )
7,086
( 3,838 )
Other (expense) income:
Interest expense, net
( 1,314 )
( 505 )
( 1,827 )
( 1,065 )
Investment loss from Melt Pharmaceuticals, net
( 477 )
( 690 )
( 947 )
( 1,236 )
Investment loss from Surface Pharmaceuticals, net
( 465 )
( 599 )
( 1,314 )
( 938 )
Investment (loss) gain from Eton Pharmaceuticals, net
( 3,584 )
4,725
( 6,419 )
( 6,125 )
Investment loss
-
-
-
-
Loss from early extinguishment of loan
( 756 )
-
( 756 )
-
Gain on forgiveness of PPP loan
-
-
1,967
-
Other (expense) income, net
( 51 )
19
( 51 )
19
Total other (expense) income, net
( 6,647 )
2,950
( 9,347 )
( 9,345 )
Total net loss including noncontrolling interests
( 2,478 )
( 260 )
( 2,261 )
( 13,183 )
Net loss attributable to noncontrolling interests
-
23
-
39
Net loss attributable to Harrow Health, Inc.
( 2,478 )
( 237 )
( 2,261 )
( 13,144 )
Preferred dividends and accretion of preferred stock discount
( 472 )
-
( 472 )
-
Net loss attributable to common stockholders
$ ( 2,950 )
$ ( 237 )
$ ( 2,733 )
$ ( 13,144 )
Basic and diluted net loss per share of common stock
$ ( 0.11 )
$ ( 0.01 )
$ ( 0.10 )
$ ( 0.51 )
Weighted average number of shares of common stock outstanding, basic and diluted
26,736,970
25,893,629
26,379,943
25,867,478
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
4
HARROW
HEALTH, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
For
the three and six months ended June 30, 2021 and 2020
(In
thousands, except for share data)
Total
Preferred Stock
Common Stock
Additional
Harrow Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interests
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at March 31, 2020
-
$ -
25,618,918
$ 26
$ 102,261
$ ( 86,950 )
$ 15,337
$ ( 309 )
$ 15,028
Issuance of common stock in connection with:
Exercise of employee stock options
-
-
253
-
-
-
-
-
-
Exercise of warrants
Exercise of warrants, shares
Vesting of RSUs
Vesting of RSUs, shares
Stock-based payment for services provided
-
-
30,000
-
83
-
83
-
83
Shares withheld related to net share settlement of equity awards
Shares withheld related to net share settlement of equity awards, shares
Issuance of preferred shares, net of discount and issuance costs
Issuance of preferred shares, net of discount and issuance
costs, shares
Redemption of preferred shares
Redemption of preferred shares, shares
Payment of preferred dividends
Stock-based compensation expense
-
-
-
-
545
-
545
-
545
Net loss
-
-
-
-
-
( 237 )
( 237 )
( 23 )
( 260 )
Balance at June 30, 2020
-
$ -
25,649,171
$ 26
$ 102,889
$ ( 87,187 )
$ 15,728
$ ( 332 )
$ 15,396
Total
Preferred Stock
Common Stock
Additional
Harrow Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interests
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at March 31, 2021
-
$ -
25,983,676
$ 26
$ 105,382
$ ( 77,183 )
$ 28,225
$ ( 355 )
$ 27,870
Issuance of common stock in connection with:
Exercise of employee stock options
-
-
5,312
-
21
-
21
-
21
Exercise of warrants
-
-
311,369
-
-
-
-
-
-
Vesting of RSUs
-
-
977,500
1
( 1 )
-
-
-
-
Shares withheld related to net share settlement of equity awards
-
-
( 383,961 )
-
( 3,171 )
-
( 3,171 )
-
( 3,171 )
Issuance of preferred shares, net of discount and issuance costs
440,000
-
-
-
10,655
-
10,655
-
10,655
Redemption of preferred shares
( 440,000 )
-
-
-
( 11,000 )
-
( 11,000 )
-
( 11,000 )
Payment of preferred dividends
-
-
-
-
( 127 )
-
( 127 )
-
( 127 )
Stock-based compensation expense
-
-
-
-
1,078
-
1,078
-
1,078
Net loss
-
-
-
-
-
( 2,478 )
( 2,478 )
-
( 2,478 )
Balance at June 30, 2021
-
$ -
26,893,896
$ 27
$ 102,837
$ ( 79,661 )
$ 23,203
$ ( 355 )
$ 22,848
Total
Preferred Stock
Common Stock
Additional
Harrow Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interests
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at December 31, 2019
-
$ -
25,526,931
$ 26
$ 101,728
$ ( 74,043 )
$ 27,711
$ ( 293 )
$ 27,418
Issuance of common stock in connection with:
Exercise of employee stock options
-
-
253
-
-
-
-
-
-
Vesting of RSUs
91,987
-
-
-
-
-
-
Stock-based payment for services provided
-
-
30,000
-
83
-
83
-
83
Stock-based compensation expense
-
-
-
-
1,078
-
1,078
-
1,078
Net loss
-
-
-
-
-
( 13,144 )
( 13,144 )
( 39 )
( 13,183 )
Balance at June 30, 2020
-
$ -
25,649,171
$ 26
$ 102,889
$ ( 87,187 )
$ 15,728
$ ( 332 )
$ 15,396
Total
Preferred Stock
Common Stock
Additional
Harrow Health, Inc.
Total Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interests
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at December 31, 2020
-
$ -
25,749,875
$ 26
$ 104,557
$ ( 77,400 )
$ 27,183
$ ( 355 )
$ 26,828
Issuance of common stock in connection with:
Exercise of employee stock options
-
-
16,613
-
48
-
48
-
48
Exercise of warrants
-
-
311,369
-
-
-
-
-
-
Vesting of RSUs
-
-
1,207,500
1
( 1 )
-
-
-
-
Shares withheld related to net share settlement of equity awards
-
-
( 391,461 )
-
( 3,228 )
-
( 3,228 )
-
( 3,228 )
Issuance of preferred shares, net of discount and issuance costs
440,000
-
-
-
10,655
-
10,655
-
10,655
Redemption of preferred shares
( 440,000 )
-
-
-
( 11,000 )
-
( 11,000 )
-
( 11,000 )
Payment of preferred dividends
-
-
-
-
( 127 )
-
( 127 )
-
( 127 )
Stock-based compensation expense
-
-
-
-
1,933
-
1,933
-
1,933
Net loss
-
-
-
-
-
( 2,261 )
( 2,261 )
-
( 2,261 )
Balance at June 30, 2021
-
$ -
26,893,896
$ 27
$ 102,837
$ ( 79,661 )
$ 23,203
$ ( 355 )
$ 22,848
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
5
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
For the
For the
Six Months
Ended
Six Months
Ended
June 30,
June 30,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss (including noncontrolling interests)
$ ( 2,261 )
$ ( 13,183 )
Adjustments to reconcile net loss to net cash provided by (used in) operating
activities:
Depreciation and amortization of property, plant and equipment
876
913
Amortization of intangible assets
79
88
Amortization of operating lease right-of-use assets
299
341
Provision for bad debt expense
36
302
Amortization of debt issuance costs and discount
288
243
Gain on forgiveness of PPP loan
( 1,967 )
-
Investment loss from Eton Pharmaceuticals, net
6,419
6,125
Investment loss from Surface Opthalmics, net
1,314
938
Investment loss from Melt Pharmaceuticals, net
947
1,236
Loss on sale and disposal of assets
-
5
Interest paid-in-kind on loan payable
-
348
Impairment of long-lived assets
-
363
Loss on early extinguishment of loan
706
-
Stock-based payment of consulting services
-
83
Stock-based compensation
1,933
1,078
Changes in assets and liabilities:
Accounts receivable
( 1,084 )
( 311 )
Inventories
59
( 540 )
Prepaid expenses and other current assets
( 85 )
( 25 )
Accounts payable and accrued expenses
1,026
( 2,253 )
Accrued payroll and related liabilities
73
1,052
Deferred revenue and customer deposits
( 10 )
( 4 )
NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES
8,648
( 3,201 )
CASH FLOWS FROM INVESTING ACTIVITIES
Net proceeds on sale investments
9,827
-
Investment in patent and trademark assets
( 22 )
( 74 )
Purchases of property, plant and equipment
( 1,360 )
( 536 )
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES
8,445
( 610 )
CASH FLOWS FROM FINANCING ACTIVITIES
Payments on finance lease obligations
( 3 )
( 3 )
Net proceeds from 8.625% notes payable, net of costs
71,073
-
Principal and exit fee payments on SWK loan
( 15,961 )
-
Net proceeds from PPP loan
-
1,967
Proceeds from SWK debt, net of costs
-
1,000
Payment of taxes for vesting of RSUs
( 3,228 )
-
Proceeds from exercise of stock options
48
-
Sale of preferred stock, net of discount and issuance costs
10,655
-
Redemption of preferred stock
( 11,000 )
-
Payment of preferred stock dividends
( 127 )
-
NET CASH PROVIDED BY FINANCING ACTIVITIES
51,457
2,964
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
68,550
( 847 )
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, beginning of
period
4,301
4,949
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, end of period
$ 72,851
$ 4,102
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH
Cash and cash equivalents
$ 72,651
$ 3,902
Restricted cash
200
200
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD
$ 72,851
$ 4,102
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for income taxes
$ -
$ -
Cash paid for interest
$ 788
$ 408
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Right-of-use asset obtained in exchange for lease obligation
$ -
$ 41
Net reduction in right-of-use assets and lease liabilities
in connection with lease modifications
$ 1,753
$ -
The
accompanying notes are an integral part of these condensed consolidated financial statements
6
HARROW
HEALTH, INC.
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the three and six months ended June 30, 2021 and 2020
(All
dollar amounts are expressed in thousands, except share and per share data)
NOTE
1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Company
and Background
Harrow
Health, Inc. (together with its subsidiaries, partially owned companies and royalty arrangements unless the context indicates or otherwise
requires, the “Company” or “Harrow”) specializes in the development, production and sale of innovative medications
that offer unique competitive advantages and serve unmet needs in the marketplace through its subsidiaries and deconsolidated companies.
The Company owns one of the nation’s leading ophthalmology-focused pharmaceutical businesses, ImprimisRx. In addition to wholly
owning ImprimisRx, the Company also has non-controlling equity positions in Surface Ophthalmics, Inc. (“Surface”) and Melt
Pharmaceuticals, Inc. (“Melt”), both companies that began as subsidiaries of Harrow. In 2020, Harrow created Visionology,
Inc. (“Visionology”), which recently launched an online eye health platform business. Harrow also owns royalty rights in
various drug candidates being developed by Surface and Melt.
Basis
of Presentation
The
Company has prepared the accompanying unaudited condensed consolidated financial statements in accordance with accounting principles
generally accepted in the United States of America (“GAAP”) for interim financial information and in accordance with the
rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, they do not include all of the information and footnotes
required by GAAP for audited financial statements. In the opinion of management, all adjustments (consisting of only normal recurring
adjustments) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June
30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021 or for any other period.
For further information, refer to the Company’s audited consolidated financial statements and footnotes thereto included in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2020.
The
accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned and majority-owned
subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Harrow
consolidates entities in which it has a controlling financial interest. The Company consolidates subsidiaries in which it holds and/or
controls, directly or indirectly, more than 50% of the voting rights. All intercompany accounts and transactions have been eliminated
in consolidation.
The
condensed consolidated balance sheets at June 30, 2021 and December 31, 2020 and the condensed consolidated statements of operations,
stockholders’ equity and cash flows for the periods ended June 30, 2021 and 2020 include our accounts and those of our wholly owned
subsidiaries, as well as our majority owned subsidiaries Mayfield Pharmaceuticals, Inc. and Stowe Pharmaceuticals, Inc.
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
following represents an update for the six months ended June 30, 2021 to the significant accounting policies described in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2020.
Risks,
Uncertainties and Liquidity
The
Company is subject to certain regulatory standards, approvals, guidelines and inspections which could impact the Company’s ability
to make, dispense, and sell certain products. If the Company was required to cease compounding and selling certain products as a result
of regulatory guidelines or inspections, this may have a material impact on the Company’s financial condition, liquidity and results
of operations.
Segments
The
Company’s chief operating decision-maker is its Chief Executive Officer who makes resource allocation decisions and assesses performance
based on financial information of our operating segments. The Company has identified two operating segments as reportable segments. See
Note 16 for more information regarding the Company’s reportable segments.
7
Noncontrolling
Interests
The
Company recognizes any noncontrolling interest as a separate line item in equity in the condensed consolidated financial statements.
A noncontrolling interest represents the portion of equity ownership in a less-than-wholly-owned subsidiary not attributable to the Company.
Generally, any interest that holds less than 50% of the outstanding voting shares is deemed to be a noncontrolling interest; however,
there are other factors, such as decision-making rights, that are considered as well . The Company includes the amount of net loss attributable
to noncontrolling interests in consolidated net loss on the face of the condensed consolidated statements of operations.
The
Company provides in the condensed consolidated statements of stockholders’ equity a reconciliation at the beginning and the end
of the period of the carrying amount of total equity, equity attributable to the parent, and equity attributable to the noncontrolling
interest that separately discloses:
(1)
Net
income or loss;
(2)
transactions
with owners acting in their capacity as owners, showing separately contributions from and distributions to owners; and
(3)
each
component of other income or loss.
Basic
and Diluted Net Loss per Common Share
Basic
net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average
number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss attributable to
common stockholders for the period by the weighted average number of common and common equivalent shares, such as stock options and warrants,
outstanding during the period. Basic and diluted net loss per share is computed using the weighted average number of shares of common
stock outstanding during the period. Common equivalent shares (using the treasury stock or “if converted” method) from stock
options, unvested restricted stock units (“RSUs”) and warrants were 4,121,398 and 5,414,504 at June 30, 2021 and 2020, respectively.
For the three and six months ended June 30, 2021 and 2020, the common equivalent shares are excluded in the calculation of diluted net
loss per share because the effect is anti-dilutive. Included in the basic and diluted net loss per share calculation were RSUs awarded
to directors that had vested, but the issuance and delivery of the shares are deferred until the director resigns. The number of shares
underlying vested RSUs at June 30, 2021 and 2020 was 235,973 and 251,746 , respectively.
The
following table shows the computation of basic and diluted net loss per share of common stock for the three and six months ended June
30, 2021 and 2020:
SCHEDULE
OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Numerator – net loss attributable to Harrow Health, Inc. common stockholders
$ ( 2,950 )
$ ( 237 )
$ ( 2,733 )
$ ( 13,144 )
Denominator - weighted average number of shares outstanding, basic and diluted
26,736,970
25,893,629
26,379,943
25,867,478
Net loss per share, basic and diluted
$ ( 0.11 )
$ ( 0.01 )
$ ( 0.10 )
$ ( 0.51 )
Investment
in Eton Pharmaceuticals, Inc.
During
the three and six months ended June 30, 2021, the Company sold 1,518,000 shares of its Eton Pharmaceuticals, Inc. (“Eton”)
common stock through an underwritten public offering at a public offering price of $ 7.00 per share
(the “Eton Stock Sale”). The gross proceeds to the Company from the Eton Stock Sale were $ 10,626 , before deducting underwriting
discounts and commissions and other offering expenses payable by the Company of $ 799 . During the three and six months ended June 30,
2021, the Company recorded a realized loss of $ 1,406 related to the sale of 1,518,000 shares of its Eton common stock.
8
Following
the Eton Stock Sale and as of June 30, 2021, the Company owns 1,982,000 shares of Eton common stock, which represents less than 10 % of
the equity interests of Eton. At June 30, 2021, the fair market value of Eton’s common stock was $ 6.16 per share. In accordance
with the Accounting Standards Update (“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and
Measurement of Financial Assets and Financial Liabilities , the Company recorded an unrealized investment gain (loss) from its Eton
common stock position of $ ( 2,178 ) and $ ( 5,013 ) and $ 4,725 and $ ( 6,125 ) during the three and six months ended June 30, 2021 and 2020,
respectively, related to the change in fair market value of its investment in Eton during the measurement period. As of June 30, 2021,
the fair market value of the Company’s investment in Eton was $ 12,209 .
As
part of the Eton Stock Sale, the Company also agreed, for a period of 180 days, not to conduct any further sales of shares of its common
stock of Eton or otherwise dispose of, directly or indirectly, any common stock of Eton (or any securities convertible into, or exercisable
or exchangeable for, the common stock of Eton).
Investment
in Melt Pharmaceuticals, Inc. – Related Party
The
Company owns 3,500,000 common shares (which is approximately 44 % of the equity interests as of June 30, 2021) of Melt and uses the equity
method of accounting for this investment, as management has determined that the Company has the ability to exercise significant influence
over the operating and financial decisions of Melt. Under this method, the Company recognizes earnings and losses in Melt in its condensed
consolidated financial statements and adjusts the carrying amount of its investment in Melt accordingly. The Company’s share of
earnings and losses are based on the Company’s ownership interest of Melt. Any intra-entity profits and losses are eliminated.
During the three months ended June 30, 2021 and 2020, the Company recorded equity in the net losses of Melt of $ 477 and $ 690 , and $ 947
and $ 1,236 during the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021 and December 31, 2020, the Company’s
investment in Melt was $ 1,594 and $ 2,506 , respectively, which includes $ 885 and $ 851 , respectively, due from Melt for reimbursable expenses
and amounts due under a Management Services Agreement between the Company and Melt (the “Melt MSA”).
See
Note 4 for more information and related party disclosure regarding Melt.
Investment
in Surface Ophthalmics, Inc. – Related Party
The
Company owns 3,500,000
common shares (which is approximately 20 %
of the equity interests following the close of
a round of financing completed by Surface at various dates from May 2021 to July 2021) of Surface and uses the equity method
of accounting for this investment, as management has determined that the Company has the ability to exercise significant influence over
the operating and financial decisions of Surface. Under this method, the Company recognizes earnings and losses in Surface in its condensed
consolidated financial statements and adjusts the carrying amount of its investment in Surface accordingly. The Company’s share
of earnings and losses are based on the Company’s ownership interest of Surface. Any intra-entity profits and losses are eliminated.
The Company recorded equity in the net losses of Surface of $ 465
and $ 599
during the three months and $ 1,314
and $ 938
during the six months ended June 30, 2021 and
2020, respectively. As of June 30, 2021 and December 31, 2020, the Company’s investment in Surface was $ 0
and $ 1,314 ,
respectively.
See
Notes 5 for more information and related party disclosure regarding Surface.
Property,
Plant and Equipment
Property,
plant and equipment is stated at cost less accumulated depreciation and amortization. Depreciation and amortization is calculated using
the straight-line method over the estimated useful life of the asset. Leasehold improvements and capital lease equipment are amortized
over the estimated useful life or remaining lease term, whichever is shorter. Software costs during the application development
stage used to meet the Company’s internal needs are generally capitalized. Computer software and hardware and furniture and equipment
are depreciated over three to five years .
Recently
Adopted Accounting Pronouncements
In
December 2019, the FASB issued ASU 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes , which simplifies the accounting
for income taxes. This guidance became effective for the Company on January 1, 2021 on a prospective basis. Adoption of this ASU did
not have a material impact on the Company’s condensed consolidated financial statements.
NOTE
3. REVENUES
The
Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers . The Company
has three primary streams of revenue: (1) revenue recognized from our sale of products within our pharmacy services, (2) revenue recognized
from a commission agreement with a third party and (3) revenue recognized from intellectual property license and asset purchase agreements.
9
Product
Revenues from Pharmacy Services
The
Company sells prescription drugs directly through our pharmacy and outsourcing facility network. Revenue from our pharmacy services division
includes: (i) the portion of the price the client pays directly to us, net of any volume-related or other discounts paid back to the
client, (ii) the price paid to us by individuals, and (iii) customer copayments made directly to the pharmacy network. Sales taxes are
not included in revenue. Following the core principles of ASC 606, we have identified the following:
1.
Identify
the contract(s) with a customer: A contract exists with a customer at the time the prescription or order is received by the Company.
2.
Identify
the performance obligations in the contract: The order received contains the performance obligations to be met, in almost all cases
the product the customer is wishing to receive. If we are unable to meet the performance obligation, the customer is notified.
3.
Determine
the transaction price: the transaction price is based on the product being sold to the customer and any related customer discounts.
These amounts are pre-determined and built into our order management software.
4.
Allocate
the transaction price to the performance obligations in the contract: The transaction price associated with the product(s) being
ordered is allocated according to the pre-determined amounts.
5.
Recognize
revenue when (or as) the entity satisfies a performance obligation: At the time of shipment from the pharmacy or outsourcing facility,
the performance obligation has been met.
The
following revenue recognition policy has been established for the pharmacy services division:
Revenues
generated from prescription or office use drugs sold by our pharmacies and outsourcing facility are recognized when the prescription
is shipped. At the time of shipment, the pharmacy services division has performed substantially all of its obligations under its client
contracts and does not experience a significant level of returns or reshipments. Determination of criteria (3) and (4) is based on management’s
judgments regarding the fixed nature of the selling prices of the products delivered and the collectability of those amounts. The Company
records reductions to revenue for discounts at the time of the initial sale. Estimated returns and allowances and other adjustments are
provided for in the same period during which the related sales are recorded and are based on actual returns history. The rate of returns
is analyzed annually to determine historical returns experience. If the historical data we use to calculate these estimates do not properly
reflect future returns, then a change in the allowance would be made in the period in which such a determination is made and revenues
in that period could be materially affected. The Company will defer any revenues received for a product that has not been delivered or
is subject to refund until such time that the Company and the customer jointly determine that the product has been delivered and no refund
will be required.
Commission
Revenues
During
the year ended December 31, 2020, the Company entered into an agreement whereby it
is paid a fee calculated based on sales it generates from a pharmaceutical product that is owned by a third party. The revenue earned
from this arrangement is recognized at the time a customer has ordered the pharmaceutical product and it has shipped from the third party
(or one of its distributors or affiliates), at which point there is no future performance obligation required by the Company and no consequential
continuing involvement on the part of the Company to recognize the associated revenue.
Intellectual
Property License Revenues
As
of June 30, 2021, we are party to four intellectual property licenses and asset purchase agreements in which we have agreed to grant
a license and which provide a customer with the right to access the Company’s intellectual property. License arrangements may consist
of non-refundable upfront license fees, data transfer fees, research reimbursement payments, exclusive license rights to patented or
patent pending compounds, technology access fees, and various performance or sales milestones. These arrangements can be multiple-element
arrangements, the revenue of which is recognized at the point in time at which the performance obligation is met.
Non-refundable
fees that are not contingent on any future performance by the Company and require no consequential continuing involvement on the part
of the Company are recognized as revenue when the license term commences and the licensed data, technology, compounded drug preparation
and/or other deliverable is delivered. Such deliverables may include physical quantities of compounded drug preparations, design of the
compounded drug preparations and structure-activity relationships, the conceptual framework and mechanism of action, and rights to the
patents or patent applications for such compounded drug preparations. The Company defers recognition of non-refundable fees if it has
continuing performance obligations without which the technology, right, product or service conveyed in conjunction with the non-refundable
fee has no utility to the licensee and that are separate and independent of the Company’s performance under the other elements
of the arrangement. In addition, if the Company’s continued involvement is required, through research and development services
that are related to its proprietary know-how and expertise of the delivered technology or can only be performed by the Company, then
such non-refundable fees are deferred and recognized over the period of continuing involvement. Guaranteed minimum annual royalties are
recognized on a straight-line basis over the applicable term.
10
Revenue
disaggregated by revenue source for the three and six months ended June 30, 2021 and 2020, consists of the following:
SCHEDULE OF DISAGGREGATED REVENUE
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Product sales, net
$ 17,297
$ 8,049
$ 32,245
$ 19,859
Commission revenues
827
-
1,312
-
License revenues
10
11
20
18
Total revenues
$ 18,134
$ 8,060
$ 33,577
$ 19,877
Deferred
revenue and customer deposits at June 30, 2021 and December 31, 2020, were $ 56 and $ 66 , respectively. All deferred revenue and customer
deposit amounts at December 31, 2020 were recognized as revenue during the six months ended June 30, 2021.
NOTE
4. INVESTMENT IN MELT PHARMACEUTICALS, INC. RELATED PARTY TRANSACTIONS
In
December 2018, the Company entered into an asset purchase agreement with Melt (the “Melt Asset Purchase Agreement”). Pursuant
to the terms of the Melt Asset Purchase Agreement, Melt was assigned certain intellectual property and related rights from the Company
to develop, formulate, make, sell, and sub-license certain Company conscious sedation and analgesia related formulations (collectively,
the “Melt Products”). Under the terms of the Melt Asset Purchase Agreement, Melt is required to make mid-single-digit royalty
payments to the Company on net sales of the Melt Products while any patent rights remain outstanding, as well as other conditions. In
January and March 2019, the Company entered into the Melt Series A Preferred Stock Agreement. See also Note 2, under the subheading
Investment
in Melt Pharmaceuticals, Inc.
In
February 2019, the Company and Melt entered into the Melt MSA, whereby the Company provides to Melt certain administrative services and
support, including bookkeeping, web services and human resources related activities, and Melt is required to pay the Company a monthly
amount of $ 10 .
As
of June 30, 2021 and December 31, 2020, the Company was due $ 885 and $ 851 , respectively, from Melt for reimbursable expenses and amounts
due under the Melt MSA. Melt did not make any payments to the Company during the three and six months ended June 30, 2021.
The
Company’s Chief Executive Officer, Mark L. Baum is a member of the Melt board of directors, and several employees of the Company
(including Mr. Baum and the Company’s Chief Financial Officer, Andrew R. Boll) entered into consulting agreements and provide consulting
services to Melt.
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE OF CONDENSED INCOME STATEMENT
For the Six Months Ended
June 30,
2021
2020
Revenues, net
$ -
$ -
Loss from operations
2,177
2,574
Net loss
$ ( 2,177 )
$ ( 2,574 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE OF CONDENSED BALANCE SHEET
At June 30,
At December 31,
2021
2020
Current assets
$ 927
$ 2,947
Non current assets
98
11
Total assets
1,025
2,958
Total liabilities
1,784
1,778
Total stockholders’ (deficit) equity
( 759 )
1,180
Total liabilities and stockholders’ equity
$ 1,025
$ 2,958
11
NOTE
5. INVESTMENT IN SURFACE OPHTHALMICS, INC. - RELATED PARTY TRANSACTIONS
The
Company entered into an asset purchase and license agreement with Surface in 2017 and amended it in April 2018 (the “Surface License
Agreements”). Pursuant to the terms of the Surface License Agreements, the Company assigned and licensed to Surface certain intellectual
property and related rights associated with Surface’s drug candidates (collectively, the “Surface Products”). Surface
is required to make mid-single-digit royalty payments to the Company on net sales of the Surface Products while any patent rights remain
outstanding.
As
of June 30, 2021, the Company owned 3,500,000
shares of Surface common stock. A Company director,
Richard L. Lindstrom, and the Company’s Chief Executive Officer, Mark L. Baum, are directors of Surface. Surface is required to
make royalty payments to Dr. Lindstrom of net sales of certain Surface products while certain patent rights remain outstanding. Dr. Lindstrom
is also a minority owner of Flying L Partners, an affiliate of the funding investor who purchased the Surface Series A Preferred Stock.
Several employees and a director of the Company (including Mr. Baum and Dr. Lindstrom) entered into consulting agreements and provide
consulting services to Surface.
The
unaudited condensed results of operations information of Surface is summarized below:
SUMMARY OF CONDENSED INCOME STATEMENT
For the Six Months Ended
June 30,
2021
2020
Revenues, net
$ -
$ -
Loss from operations
4,712
3,127
Net loss
$ ( 4,712 )
$ ( 3,127 )
The
unaudited condensed balance sheet information of Surface is summarized below:
SUMMARY OF CONDENSED BALANCE SHEET
At June 30,
At December 31,
2021
2020
Current assets
$ 25,786
$ 9,074
Non current assets
43
45
Total assets
25,829
9,119
Total liabilities
1,771
1,666
Total stockholders’ equity
24,058
7,453
Total liabilities and stockholders’ equity
$ 25,829
$ 9,119
NOTE
6. RESTRICTED CASH
The
restricted cash at June 30, 2021 and December 31, 2020 consisted of funds held in a money market account. At June 30, 2021 and December
31, 2020, the restricted cash was recorded at amortized cost, which approximates fair value.
At
June 30, 2021 and December 31, 2020, the funds held in a money market account of $ 200 were classified as a current asset. The money market
account funds are required as collateral as additional security for the Company’s New Jersey facility lease.
12
NOTE
7. INVENTORIES
Inventories
are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, commercial pharmaceutical
products, related laboratory supplies and active pharmaceutical ingredients. The composition of inventories as of June 30, 2021 and December
31, 2020 was as follows:
SCHEDULE OF INVENTORIES
June
30,
2021
December
31,
2020
Raw materials
$ 1,990
$ 2,501
Work in progress
17
17
Finished goods
1,896
1,444
Total inventories
$ 3,903
$ 3,962
NOTE
8. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at June 30, 2021 and December 31, 2020, consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
June
30,
2021
December
31,
2020
Prepaid insurance
$ 120
$ 160
Other prepaid expenses
607
401
Deposits and other current assets
74
190
Total prepaid expenses and other current assets
$ 801
$ 751
NOTE
9. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment at June 30, 2021 and December 31, 2020, consisted of the following:
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT
June
30,
2021
December
31,
2020
Property, plant and equipment, net:
Computer software and hardware
$ 1,427
$ 1,370
Internal use software costs in development
803
337
Furniture and equipment
441
418
Lab and pharmacy equipment
4,225
3,426
Leasehold improvements
5,735
5,720
Property, plant and equipment, gross
12,631
11,271
Accumulated depreciation and amortization
( 7,694 )
( 6,818 )
Property,
plant and equipment, net
$ 4,937
$ 4,453
For
the three and six months ended June 30, 2021, depreciation and amortization related to the property, plant and equipment was $ 412 and
$ 876 , respectively. For the three and six months ended June 30, 2020, depreciation and amortization related to the property, plant and
equipment was $ 465 and $ 913 , respectively.
13
NOTE
10. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at June 30, 2021 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
Amortization
periods
(in
years)
Cost
Accumulated
amortization
Impairment
Net
carrying
value
Patents
17 - 19
$ 540
$ ( 60 )
$ -
$ 480
Licenses
20
50
( 6 )
-
44
Trademarks
Indefinite
358
-
-
358
Customer relationships
3 - 15
1,519
( 520 )
-
999
Trade name
5
5
( 5 )
-
-
Non-competition clause
3 - 4
50
( 50 )
-
-
State
pharmacy licenses
25
8
( 7 )
-
1
$ 2,530
$ ( 648 )
$ -
$ 1,882
Amortization
expense for intangible assets for the three and six months ended June 30, 2021 and 2020 was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
For
the
Three
Months Ended
For
the
Six
Months Ended
June
30,
June
30,
2021
2020
2021
2020
Patents
$ 6
$ 8
$ 12
$ 19
Licenses
-
-
1
1
Customer
relationships
33
35
66
68
$ 39
$ 43
$ 79
$ 8 8
Estimated
future amortization expense for the Company’s intangible assets at June 30, 2021 is as follows:
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Remainder of 2021
$ 110
2022
188
2023
188
2024
161
2025
148
Thereafter
729
Intangible
assets
$ 1,524
NOTE
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
June
30,
2021
December
31,
2020
Accounts payable
$ 3,882
$ 3,645
Other accrued expenses
49
49
Accrued interest
1,276
238
Accrued exit fee for loan payable
-
800
Total accounts payable and accrued expenses
5,207
4,732
Less: Current portion
( 5,207 )
( 3,932 )
Non-current total accrued expenses
$ -
$ 800
14
NOTE
12. DEBT
8.625%
Senior Notes Due 2026
In
April 2021, the Company closed an offering of $ 50,000 aggregate principal amount of 8.625% senior notes due in April 2026 and in May
2021 issued an additional $ 5,000 of such notes pursuant to the full exercise of the underwriters’ option to purchase additional
notes (collectively, the “April Notes”). The April Notes were sold to investors at a par value of $ 25.00 per April Note and
the offering resulted in net proceeds to the Company of approximately $ 51,909 after deducting underwriting discounts and commissions
and expenses of $ 3,091 . In June 2021, in a further issuance of the April Notes, the Company sold an additional $ 20,000 aggregate principal
amount of such notes (the “June Notes,” and together with the April Notes, the “Notes”), at a price of $ 25.75
per June Note, with interest of $ 278 on the June Notes being accrued from April 20, 2021 as of the date of issuance. The June offering
resulted in net proceeds to the Company of approximately $ 19,164 after deducting underwriting discounts and commissions and expenses
of $ 1,158 and a premium on note issuance of $ 322 . The June Notes are treated as a single series with the April Notes under the indenture
governing the April Notes, dated as of April 20, 2021, and have the same terms as the April Notes (other than the initial offering price
and issue date). T he Notes are senior unsecured obligations of the Company and rank equally
in right of payment with all of our other existing and future senior unsecured and unsubordinated indebtedness. The Notes are effectively
subordinated in right of payment to all of the Company’s existing and future secured indebtedness and structurally subordinated
to all existing and future indebtedness of the Company’s subsidiaries, including trade payables. The Notes bear interest at a rate
of 8.625 % per annum. Interest on the Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year,
commencing on July 31, 2021. The Notes will mature on April 30, 2026. The issuance costs were recorded
as a debt discount and are being amortized as interest expense, net of the amortization of the premium on note issuance, over the term
of the Notes using the effective interest rate method.
Prior
to February 1, 2026, the Company may, at its option, redeem the Notes, in whole at any time or in part from time to time, at a redemption
price equal to 100% of the principal amount of the Notes to be redeemed, plus a make-whole amount, if any, plus accrued and unpaid interest
to, but excluding, the date of redemption. The Company may redeem the Notes for cash in whole or in part at any time at our option on
or after February 1, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid interest
to, but excluding, the date of redemption. On and after any redemption date, interest will cease to accrue on the redeemed Notes.
Interest
expense related to the Notes totaled $ 1,466 for the three and six months ended June 30, 2021, and included amortization of debt issuance
costs and discount of $ 192 for the three and six months ended June 30, 2021.
SWK
Senior Note – Paid in April 2021
In
July 2017, the Company and several of its wholly owned subsidiaries entered into a term loan and security agreement in the principal
amount of $ 16,000 (the “SWK Loan Agreement” or “SWK Loan”) with SWK Funding LLC and its partners (collectively,
“SWK”), as lender and collateral agent. The SWK Loan Agreement was fully funded at closing with a five-year term; however,
such term could be reduced to four years if certain revenue requirements were not achieved. The SWK Loan was secured by substantially
all of the Company’s assets, including its intellectual property rights. The SWK Loan was subsequently amended in May 2019 and
again in April 2020. The SWK Loan bore an interest rate equal to the three-month London Inter-Bank Offered Rate (subject to a minimum
of 2.00 % ), plus an applicable margin of 10.00 % (the “Margin Rate”); provided that, if, two days prior to a payment date,
the Company provided SWK evidence that the Company has achieved a leverage ratio as of such date of less than 4.00:1:00, the Margin Rate
shall equal 9.00%; and if the Company had achieved a leverage ratio as of such date of less than 3.00:1:00, the Margin Rate shall equal
7.00%. The leverage ratio means, as of any date of determination, the ratio of: (a) indebtedness as of such date to (b) EBITDA (as defined
in the SWK Loan), of the Company for the immediately preceding 12 month period, adding-back (i) actual litigation expenses for the immediately
preceding 12 month period, minus (ii) actual litigation expenses for the immediately preceding 3 month period multiplied by 4.
A
summary of the material changes contained in the amendment entered into with SWK in April 2020 was as follows:
●
SWK
agreed to make available to the Company, and the Company drew down on, an additional principal amount of $ 1,000 ;
●
The
definition of the first amortization date was changed to August 14, 2020, permitting the Company to pay interest only on the principal
amount loaned for the next payment (payments are due on a quarterly basis) following the SWK Second Amendment; and
●
The
interest payment of $ 358 due May 14, 2020 was paid in-kind by increasing the principal amount of the term loans by an amount equal
to the interest accrued as of such date.
15
Interest
expense related to the SWK Loan Agreement, as amended, amounted to $ 138 and $ 647 for the three and six months ended June 30, 2021, respectively,
and $ 505 and $ 1,065 for the three and six months ended June 30, 2020, respectively, and included amortization of debt issuance costs
and discount of $ 0 and $ 96 for the three and six months ended June 30, 2021, respectively, and $ 83 and $ 243 for the three and six months
ended June 30, 2020, respectively.
In
April 2021, the Company paid $ 15,540 related to all outstanding obligations to SWK under the SWK Loan, including outstanding principal,
accrued interest, accrued exit fee and related expenses and recorded a loss from early extinguishment of $ 756 related to the SWK Loan
during the three and six months ended June 30, 2021.
Paycheck
Protection Program Loan – Forgiven in March 2021
In
April 2020, the Company entered into an unsecured promissory note and related Business Loan Agreement with Renasant Bank, as lender,
for a loan (the “PPP Loan”) in the principal amount of $ 1,967
and received cash proceeds of the same amount,
pursuant to the Paycheck Protection Program (the “PPP”) under the Federal Coronavirus Aid, Relief, and Economic Security
Act (the “CARES Act”), which was enacted March 27, 2020. The PPP is administered by the U.S. Small Business Administration
(the “SBA”). On March 30, 2021, the Company received a notice of forgiveness of the full balance of the PPP Loan, including
all accrued interest, in accordance with the terms and conditions of the CARES Act. Related to the forgiveness, the Company recorded
a gain on the forgiveness of the PPP Loan for the loan balance of $ 1,967
in the accompanying condensed consolidated statement
of operations for the six months ended June 30, 2021.
At
June 30, 2021, future minimum payments under the Company’s debt were as follows:
SUMMARY OF FUTURE MINIMUM PAYMENTS
Amount
Remainder of 2021
$ 3,308
2022
6,562
2023
6,562
2024
6,580
2025
6,562
2026
77,158
Total minimum payments
106,732
Less: amount representing interest payments
( 31,732 )
Notes payable, gross
75,000
Less: unamortized discount, net of premium
( 3,735 )
Notes payable, net of unamortized discount
$ 71,265
NOTE
13. LEASES
The
Company leases office and laboratory space under non-cancelable operating leases listed below. These lease agreements have remaining
terms between one to four years and contain various clauses for renewal at the Company’s option.
●
An
operating lease for 10,200 square feet of office space in San Diego, California that expires in December 2021 ;
●
An
operating lease for 26,400 square feet of lab, warehouse and office space in Ledgewood, New Jersey that expires in July 2026 , with
an option to extend the term for two additional five-year periods . This includes an amendment that was made effective July 2020 that
extended the term of the original lease and added 1,400 of additional square footage to the lease and another amendment entered into
in May 2021 that extended the term of the lease to July 2027 ; and
●
An
operating lease for 5,500 square feet of office space in Nashville, Tennessee that expires in December 2024 , with an option to extend
the term for two additional five-year periods .
In
May 2021, the Company amended its New Jersey lease to include the addition of 8,926 square feet of space (the “May Lease Amendment”),
which will expire in July 2027 . The Company expects to take possession of this additional space in September 2021, which will trigger
the commencement of the May Lease Amendment. Since the commencement date of the May Lease Amendment is expected to occur after June 30,
2021, right-of-use assets and operating lease liabilities associated with the May Lease Amendment are not included in the Company’s
condensed consolidated balance sheets as of June 30, 2021.
16
At
June 30, 2021, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
held by the Company were 6.32 % and 14.08 years, respectively.
During
the three and six months ended June 30, 2021, cash paid for amounts included for the operating lease liabilities was $ 251 and $ 502 , respectively,
and the Company recorded operating lease expense of $ 241 and $ 502 included in selling, general and administrative expenses, respectively.
Future
lease payments under operating leases as of June 30, 2021 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
Operating
Leases
Remainder of 2021
$ 502
2022
585
2023
600
2024
617
2025
433
Thereafter
5,146
Total minimum lease payments
7,883
Less: amount representing interest payments
( 2,703 )
Total operating lease liabilities
5,180
Less: current portion, operating lease liabilities
( 485 )
Operating lease liabilities, net of current portion
$ 4,695
The
Company also has a finance lease that is included in its lease accounting but is not considered significant.
Future
lease payments under the non-cancelable finance lease as of June 30, 2021 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER FINANCE LEASE
Finance
Leases
Remainder of 2021
$ 5
2022
9
2023
9
2024
1
Total minimum lease payments
24
Less: amount representing interest payments
( 2 )
Present value of future minimum lease payments
22
Less: current portion, finance lease obligation
( 8 )
Finance lease obligation, net of current portion
$ 14
At
June 30, 2021, the weighted average incremental borrowing rate and the weighted average remaining lease term for the finance lease held
by the Company were 6.36 % and 2.58 years, respectively.
For
the three and six months ended June 30, 2021, depreciation expense related to the equipment held under the finance lease obligation was
$ 2 and $ 4 , respectively.
For
the three and six months ended June 30, 2021, cash paid and expense recognized for interest expense related to the finance lease obligation
was $ 0 and $ 1 , respectively.
NOTE
14. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Preferred
Stock
At
June 30, 2021 and 2020, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares of preferred
stock issued and outstanding.
17
Series
B Cumulative Preferred Stock – Redeemed
In
May 2021, the Company sold 440,000
shares of the Company’s Series B Cumulative
Preferred Stock, par value $ 0.001
per share and liquidation preference of $ 25.00
per share (the “Series B Preferred Stock”),
for a net purchase price of approximately $ 10,655 .
The Series
B Preferred Stock was not convertible into our common stock, had no voting rights ,
except as required by Delaware law, and was redeemable by the Company at any time. Holders of Series B Preferred Stock were entitled
to cumulative cash dividends at the rate of 9.50 %
of the $ 25.00
liquidation preference per year; provided, however,
that for each thirty (30) day period following May 5, 2021, the dividend rate increased at various rates, except as otherwise limited
by applicable law. Dividends were payable quarterly in arrears, on or about the 15th of January, April, July and October, beginning on
or about July 15, 2021.
In
June 2021, the Company redeemed all of the outstanding shares of the Company’s Series B Preferred Stock, par value $ 0.001 per share.
The redemption price for the 440,000 shares of Series B Preferred Stock outstanding was equal to $ 25.00 per share, plus accrued and unpaid
dividends, which in aggregate totaled $ 11,127 . During the three and six months ended June 30, 2021, the Company recorded preferred stock
cash dividends and deemed dividends equal to $ 472 .
Common
Stock
During
the six months ended June 30, 2021, the Company issued 311,369 shares of its common stock upon the cashless exercise of warrants to purchase
406,539 shares of common stock with exercise prices between $ 1.79 and $ 3.75 per share.
During
the six months ended June 30, 2021, the Company issued 16,613 shares of its common stock upon the exercise of options to purchase 16,613
shares of common stock with exercise prices between $ 1.70 and $ 4.29 per share and received net proceeds of $ 48 .
During
the six months ended June 30, 2021, the Company issued 715,871 shares of its common stock to Mark L. Baum, its CEO, related to the vesting
of 1,050,000 performance-based restricted stock units. The Company withheld issuance of 334,129 shares of common stock valued at $ 2,760
for payroll tax purposes.
During
the six months ended June 30, 2021, the Company issued 100,168 shares of common stock to Andrew R. Boll, its CFO, related to the vesting
of 157,500 performance-based restricted stock units. The Company withheld issuance of 57,332 shares of common stock to Mr. Boll for payroll
tax purposes valued at $ 468 .
During
the six months ended June 30, 2021, 35,510 shares of the Company’s common stock underlying RSUs issued to directors vested, but
the issuance and delivery of these shares are deferred until the director resigns.
Stock
Option Plan
On
September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and Awards
Plan, which was subsequently amended on November 5, 2008, February 26, 2012, July 18, 2012, May 2, 2013 and September 27, 2013 (as amended,
the “2007 Plan”). The 2007 Plan reached its term in September 2017, and we can no longer issue additional awards under this
plan, however, options previously issued under the 2007 Plan will remain outstanding until they are exercised, reach their maturity or
are otherwise cancelled/forfeited. On June 13, 2017, the Company’s Board of Directors and stockholders adopted the Company’s
2017 Incentive Stock and Awards Plan which was subsequently amended on June 3, 2021 (as amended, the “2017 Plan” together
with the 2007 Plan, the “Plans”). As of June 30, 2021, the 2017 Plan provides for the issuance of a maximum of 6,000,000
shares of the Company’s common stock. The purpose of the Plans are to attract and retain directors, officers, consultants, advisors
and employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of such
persons in the Company’s development and financial success. Under the Plans, the Company is authorized to issue incentive stock
options intended to qualify under Section 422 of the Internal Revenue Code, non-qualified stock options, restricted stock units and restricted
stock. The Plans are administered by the Compensation Committee of the Company’s Board of Directors. The Company had 3,967,251
shares available for future issuances under the 2017 Plan at June 30, 2021.
18
Stock
Options
A
summary of stock option activity under the Plans for the six months ended June 30, 2021 is as follows:
SCHEDULE OF STOCK OPTION PLAN ACTIVITY
Number of Shares
Weighted
Avg.
Exercise
Price
Weighted Avg. Remaining Contractual
Life
Aggregate
Intrinsic
Value
Options outstanding - January 1, 2021
3,030,033
$ 5.43
Options granted
67,000
$ 8.07
Options exercised
( 16,613 )
$ 2.99
Options cancelled/forfeited
( 29,945 )
$ 5.32
Options outstanding - June 30, 2021
3,050,475
$ 5.50
5.28
$ 11,555
Options exercisable
2,333,132
$ 5.01
4.85
$ 9,985
Options vested and expected to vest
2,978,866
$ 5.46
5.25
$ 11,399
The
aggregate intrinsic value in the table above represents the total pre-tax amount of the proceeds, net of exercise price, which would
have been received by option holders if all option holders had exercised and immediately sold all options with an exercise price lower
than the market price on June 30, 2021, based on the closing price of the Company’s common stock of $ 9.29 on that date.
During
the six months ended June 30, 2021, the Company granted stock options to certain employees and a consultant. The stock options were granted
with an exercise price equal to the current market price of the Company’s common stock, as reported by the securities exchange
on which the common stock was then listed, at the grant date and have contractual terms of 10 years. Vesting terms for options granted
to employees and consultants during the six months ended June 30, 2021 included the following vesting schedules: 25% of the shares subject
to the option vest and become exercisable on the first anniversary of the grant date and the remaining 75% of the shares subject to the
option vest and become exercisable quarterly in equal installments thereafter over three years. Certain option awards provide for accelerated
vesting if there is a change in control (as defined in the Plans) and in the event of certain modifications to the option award agreement.
The
fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model. The expected term
of options granted to employees and directors was determined in accordance with the “simplified approach,” as the Company
has limited, relevant, historical data on employee exercises and post-vesting employment termination behavior. The expected risk-free
interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time
of the grant. The financial statement effect of forfeitures is estimated at the time of grant and revised, if necessary, if the actual
effect differs from those estimates. For option grants to employees and directors, the Company assigns a forfeiture factor of 10%. These
factors could change in the future, which would affect the determination of stock-based compensation expense in future periods. Utilizing
these assumptions, the fair value is determined at the date of grant.
The
table below illustrates the fair value per share determined using the Black-Scholes-Merton option pricing model with the following assumptions
used for valuing options granted to employees:
SCHEDULE OF FAIR VALUE ASSUMPTIONS
2021
Weighted-average fair value of options granted
$ 4.96
Expected terms (in years)
6.11
Expected volatility
69 %
Risk-free interest rate
0.39 - 0.45 %
Dividend yield
-
The
following table summarizes information about stock options outstanding and exercisable at June 30, 2021:
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE
Options Outstanding
Options Exercisable
Range of Exercise Prices
Number
Outstanding
Weighted
Average
Remaining
Contractual
Life
in Years
Weighted
Average
Exercise
Price
Number Exercisable
Weighted
Average
Exercise
Price
$ 1.47 - $ 2.60
760,318
5.13
$ 2.06
755,208
$ 2.06
$ 2.76 - $ 4.66
506,566
5.22
$ 3.98
449,872
$ 3.98
$ 5.49 - $ 6.36
470,350
6.59
$ 6.12
348,128
$ 6.14
$ 6.64 - $ 8.99
1,313,241
4.93
$ 7.86
779,924
$ 7.96
$ 1.47 - $ 8.99
3,050,475
5.28
$ 5.50
2,333,132
$ 5.01
As
of June 30, 2021, there was approximately $ 2,012 of total unrecognized compensation expense related to unvested stock options granted
under the Plans. That expense is expected to be recognized over the weighted-average remaining vesting period of 5.17 years. The stock-based
compensation for all stock options was $ 569 and $ 1,021 during the three and six months ended June 30, 2021, respectively.
19
The
intrinsic value of options exercised during the three and six months ended June 30, 2021 was $ 14 and $ 77 , respectively.
Restricted
Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including performance and market-based vesting criteria.
The grant date fair value of the RSUs, which has been determined based upon the market value of the Company’s common stock on the
grant date, is expensed over the vesting period of the RSUs.
During
the six months ended June 30, 2021, 300,000 RSUs with a fair market value of $ 2,670 were issued to certain employees; the RSUs vest in
full on the third anniversary of the grant date.
During
the six months ended June 30, 2021, the Company’s board of directors were granted 38,576 RSUs with a fair market value of $ 400
which vest in equal quarterly installments over one year.
A
summary of the Company’s RSU activity and related information for the six months ended June 30, 2021 is as follows:
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Number of RSUs
Weighted Average Grant Date Fair Value
RSUs unvested - January 1, 2021
1,601,509
$ 3.14
RSUs granted
338,576
$ 9.07
RSUs vested
( 1,243,009 )
$ 2.24
RSUs cancelled/forfeited
-
-
RSUs unvested at June 30, 2021
697,076
$ 7.61
As
of June 30, 2021, the total unrecognized compensation expense related to unvested RSUs was approximately $ 3,606 , which is expected to
be recognized over a weighted-average period of 1.74 years, based on estimated and actual vesting schedules of the applicable RSUs. The
stock-based compensation for RSUs during the three and six months ended June 30, 2021 was $ 481 and $ 827 , respectively.
Warrants
From
time to time, the Company issues warrants to purchase shares of the Company’s common stock to investors, lenders, underwriters
and other non-employees for services rendered or to be rendered in the future, or pursuant to settlement agreements.
A
summary of warrant activity for the six months ended June 30, 2021 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
Number of Shares Subject to Warrants Outstanding
Weighted Avg. Exercise Price
Warrants outstanding - January 1, 2021
780,386
$ 2.12
Granted
-
Exercised
( 406,539 )
2.16
Expired
-
Warrants outstanding and exercisable - June 30, 2021
373,847
$ 2.08
Weighted average remaining contractual life of the outstanding warrants in years - June 30, 2021
3.05
20
Warrants
outstanding and exercisable as of June 30, 2021 are as follows:
SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
Warrant Series
Issue Date
Warrants
Outstanding
Exercise
Price
Expiration
Date
Lender warrants
7/19/2017
373,847
$ 2.08
7/19/2024
Subsidiary
Stock-Based Transactions
The
Company recognized $ 28 and $ 85 in stock-based compensation expense related to subsidiary stock options during the three and six months
ended June 30, 2021, respectively.
Stock-Based
Compensation Summary
The
Company recorded stock-based compensation related to equity instruments granted to employees, directors and consultants as follows:
SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Employees - selling, general and administrative
923
436
1,678
872
Employees - R&D
55
-
55
-
Directors - selling, general and administrative
100
96
200
193
Consultants - selling, general and administrative
-
96
-
96
Total
$ 1,078
$ 628
$ 1,933
$ 1,161
NOTE
15. COMMITMENTS AND CONTINGENCIES
Legal
Novel
Drug Solutions et al.
In
April 2018, Novel Drug Solutions, LLC and Eyecare Northwest, PA (collectively “NDS”) filed a lawsuit against the Company
in the U.S. District Court of Delaware asserting various claims, including breach of contract. The claims stem from an asset purchase
agreement between the Company and NDS entered into in 2013. In July 2019, NDS filed a second amended complaint which added claims related
to its purported termination of the APA. In October 2019, NDS voluntarily dismissed all but two claims, leaving only claims related to
the scope and performance of the post-termination obligations to be litigated. Trial is currently set to begin in November 2021. NDS
is seeking damages, interest, attorneys’ fees and other costs. The Company believes the claims are meritless and has previously
and will continue to dispute all claims asserted against it and intends to vigorously defend against these allegations. Nonetheless,
the Company cannot predict the eventual outcome of this litigation and it could result in substantial costs, losses and a diversion of
management’s resources and attention, which could harm the Company’s business and the value of its common stock.
Product
and Professional Liability
Product
and professional liability litigation represents an inherent risk to all firms in the pharmaceutical and pharmacy industry. We utilize
traditional third-party insurance policies with regard to our product and professional liability claims. Such insurance coverage at any
given time reflects current market conditions, including cost and availability, when the policy is written.
John
Erick et al.
In
January 2018, John Erick and Deborah Ferrell, successors-in-interest and heirs of Jade Erick, (collectively “Erick”) filed
a lawsuit in the San Diego County Superior against Kim Kelly, ND, MPH asserting claims related to the death of Jade Erick. In April 2018,
Erick filed an amendment to the lawsuit, naming the Company as a co-defendant. In September 2018, co-defendant Dr. Kelly filed a cross-complaint
against the Company and various entities affiliated with Spectrum Laboratory Products, Inc., Spectrum Chemical Manufacturing Corp. and
Spectrum Pharmacy Products, Inc. (collectively “Spectrum”). The cross-complaint seeks indemnity and contribution from the
Company and Spectrum. The Company answered the claims filed by Dr. Kelly in October 2018. The case is currently in the discovery phase.
Trial is currently set to begin October 2021. Erick is seeking unspecified damages, interest, attorneys’ fees and other costs.
The Company believes the claims are meritless and has previously and will continue to dispute all claims asserted against it and intends
to vigorously defend against these allegations. The Company’s insurance carrier has reserved its rights to seek contribution from
the Company if the plaintiffs prevail on certain claims which the carrier alleges are uncovered. The Company believes the policy covers
all claims. Nonetheless, the Company cannot predict the eventual outcome of this litigation, it could result in substantial costs, losses
and a diversion of management’s resources and attention, which could harm the Company’s business and the value of its common
stock.
21
General
and Other
In
the ordinary course of business, the Company may face various claims brought by third parties and it may, from time to time, make claims
or take legal actions to assert its rights, including intellectual property disputes, contractual disputes and other commercial disputes.
Any of these claims could subject the Company to litigation.
Indemnities
In
addition to the indemnification provisions contained in the Company’s governing documents, the Company generally enters into separate
indemnification agreements with each of the Company’s directors and officers. These agreements require the Company, among other
things, to indemnify the director or officer against specified expenses and liabilities, such as attorneys’ fees, judgments, fines
and settlements, paid by the individual in connection with any action, suit or proceeding arising out of the individual’s status
or service as the Company’s director or officer, other than liabilities arising from willful misconduct or conduct that is knowingly
fraudulent or deliberately dishonest, and to advance expenses incurred by the individual in connection with any proceeding against the
individual with respect to which the individual may be entitled to indemnification by the Company. The Company also indemnifies its lessors
in connection with its facility leases for certain claims arising from the use of the facilities. These indemnities do not provide for
any limitation of the maximum potential future payments the Company could be obligated to make. Historically, the Company has not incurred
any payments for these obligations and, therefore, no liabilities have been recorded for these indemnities in the accompanying condensed
consolidated balance sheets.
Klarity
License Agreement – Related Party
The
Company entered into a license agreement in April 2017 and as amended in April 2018, (the “Klarity License Agreement”) with
Richard L. Lindstrom, M.D., a member of its Board of Directors. Pursuant to the terms of the Klarity License Agreement, the Company licensed
certain intellectual property and related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license the topical ophthalmic
solution Klarity designed to protect and rehabilitate the ocular surface (the “Klarity Product”).
Under
the terms of the Klarity License Agreement, the Company is required to make royalty payments to Dr. Lindstrom ranging from 3% - 6% of
net sales, dependent upon the final formulation of the Klarity Product sold. In addition, the Company is required to make certain milestone
payments to Dr. Lindstrom including: (i) an initial payment of $ 50 upon execution of the Klarity License Agreement, (ii) a second payment
of $ 50 following the first $ 50 in net sales of the Klarity Product; and (iii) a final payment of $ 50 following the first $ 100 in net
sales of the Klarity Product. All of the above referenced milestone payments are payable at the Company’s election in cash or shares
of the Company’s restricted common stock. Payments totaling $ 35 and $ 70 were made during the three and six months ended June 30,
2021, respectively. Payments totaling $ 0 and $ 55 were made during the three and six months ended June 30, 2020, respectively. Royalty
expense of $ 44 and $ 79 was incurred during the three and six months ended June 30, 2021, respectively, and $ 44 is included in accounts
payable to Dr. Lindstrom as of June 30, 2021. Royalty expense of $ 27 and $ 56 was incurred during the three and six months ended June
30, 2020, respectively.
Injectable
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Lindstrom APA”) with Dr. Lindstrom, a member of
its Board of Directors. Pursuant to the terms of the Lindstrom APA, the Company acquired certain intellectual property and related rights
from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic injectable product (the “Lindstrom Product”).
Under
the terms of the Lindstrom APA, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 3% of net sales,
dependent upon the final formulation and patent protection of the Lindstrom Product sold. In addition, the Company is required to make
certain milestone payments to Dr. Lindstrom including an initial payment of $ 33 upon execution of the Lindstrom APA. Dr. Lindstrom was
paid $ 7 and $ 14 in cash during the three and six months ended June 30, 2021, respectively. Dr. Lindstrom was paid $ 0 and $ 7 in cash during
the three and six months ended June 30, 2020, respectively. The Company incurred royalty expense of $ 7 and $ 14 and $ 4 and $ 42 related
to the Lindstrom APA during the three and six months ended June 30, 2021, and 2020, respectively.
22
Eyepoint
Commercial Alliance Agreement
In
August 2020, the Company, through its wholly owned subsidiary ImprimisRx, LLC, entered into a Commercial Alliance Agreement (the “Dexycu
Agreement”) with Eyepoint Pharmaceuticals, Inc. (“Eyepoint”), pursuant to which Eyepoint granted the Company the non-exclusive
right to co-promote DEXYCU ® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation
following ocular surgery in the United States. Pursuant
to the Dexycu Agreement , Eyepoint will pay the Company a fee calculated based on the quarterly
sales of DEXYCU in excess of predefined volumes to specific customers of the Company in the U.S. Under the terms of the Dexycu
Agreement , the Company shall use commercially reasonable efforts to promote and market DEXYCU in the U.S.
Subject
to early termination, the Dexycu Agreement expires on August 1, 2025, subject to specified
notice periods and specified limitations, either party may terminate the Dexycu Agreement
in the event of (i) uncured material breach by the other party or (ii) if DEXYCU ceases to have “pass-through” payment status.
In addition, subject to certain limitations, the Company may terminate the Dexycu Agreement
(i) for convenience subject to an extended specified notice period or (ii) in the event Eyepoint undergoes a change of control. Eyepoint
may terminate the Dexycu Agreement , subject to specified notice periods and specified limitations,
if the Company fails to achieve certain minimum sales levels during specified periods. During the three and six months ended June 30,
2021, the Company recorded $ 827 and $ 1,312 , respectively, in commission revenues related to the Dexycu Agreement.
Sales
and Marketing Agreements
The
Company has entered various sales and marketing agreements with certain organizations to provide exclusive and non-exclusive sales and
marketing representation services to Harrow in select geographies in the U.S. in connection with the Company’s ophthalmic pharmaceutical
compounded formulations or related products.
Under
the terms of the sales and marketing agreements, the Company is generally required to make commission payments equal to 10 % - 14 % of
net sales for products above and beyond the initial existing sales amounts. In addition, the Company is required to make periodic milestone
payments to certain organizations in shares of the Company’s restricted common stock if net sales in the assigned territory reach
certain future levels by the end of their terms. Commission expenses of $ 1,032 and $ 1,836 and $ 318 and $ 921 were incurred under these
agreements during the three and six months ended June 30, 2021, and 2020, respectively.
Asset
Purchase, License and Related Agreements
The
Company has acquired and sourced intellectual property rights related to certain proprietary innovations from certain inventors and related
parties (the “Inventors”) through multiple asset purchase agreements, license agreements, strategic agreements and commission
agreements. In general, these agreements provide that the Inventors will cooperate with the Company in obtaining patent protection for
the acquired intellectual property and that the Company will use commercially reasonable efforts to research, develop and commercialize
a product based on the acquired intellectual property. In addition, the Company has acquired a right of first refusal on additional intellectual
property and drug development opportunities presented by these Inventors.
In
consideration for the acquisition of the intellectual property rights, the Company is obligated to make payments to the Inventors based
on the completion of certain milestones, generally consisting of: (1) a payment payable within 30 days after the issuance of the first
patent in the United States arising from the acquired intellectual property (if any); (2) a payment payable within 30 days after the
Company files the first investigational new drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”)
for the first product arising from the acquired intellectual property (if any); (3) for certain of the Inventors, a payment payable within
30 days after the Company files the first new drug application with the FDA for the first product arising from the acquired intellectual
property (if any); and (4) certain royalty payments based on the net receipts received by the Company in connection with the sale or
licensing of any product based on the acquired intellectual property (if any), after deducting (among other things) the Company’s
development costs associated with such product. If, following five years after the date of the applicable asset purchase agreement, the
Company either (a) for certain of the Inventors, has not filed an IND or, for the remaining Inventors, has not initiated a study where
data is derived, or (b) has failed to generate royalty payments to the Inventors for any product based on the acquired intellectual property,
the Inventors may terminate the applicable asset purchase agreement and request that the Company re-assign the acquired technology to
the Inventors. Royalty expenses of $ 261 and $ 493 and $ 117 and $ 261 were incurred under these agreements for the three and six months
ended June 30, 2021 and 2020, respectively, and $ 272 and $ 431 are included in accounts payable at June 30, 2021 and 2020, respectively.
23
Mayfield
Pharmaceuticals MAY-66 License Termination
In
May 2021, Mayfield terminated the License Agreement (the “TGV License”) with TGV-Health, LLC and affiliated entities (collectively,
“TGV”), pursuant to which it acquired intellectual property rights for use in the women’s health field, related to
Mayfield’s proprietary drug candidate MAY-66. Concurrent with the termination, TGV returned to Mayfield 300,000 shares of Mayfield’s
common stock, constituting all of the equity held by TGV. Mayfield has no outstanding or remaining obligations under the TGV License.
Mayfield
Pharmaceuticals MAY-44 APA Termination
In
May 2021, Mayfield and Harrow terminated their asset purchase agreement dated January 2020 for intellectual property rights associated
with Mayfield’s drug candidate MAY-44 with Elle Pharmaceutical LLC (the “MAY-44 APA”). As part of the termination,
Mayfield re-acquired 350,000 shares of its common stock from Elle. Mayfield has no outstanding or remaining obligations related to the
MAY-44 APA.
Stowe
License Termination
In
May 2021, Stowe terminated the License Agreement (the “Stowe License”) with TGV, pursuant to which it acquired intellectual
property rights for use in the ophthalmic field, related to Stowe’s proprietary drug candidate STE-006. Concurrent with the termination,
TGV returned to Stowe 1,750,000 shares of Stowe’s common stock, constituting all of the equity held by TGV. Stowe has no outstanding
or remaining obligations under the Stowe License.
NOTE
16. SEGMENT INFORMATION AND CONCENTRATIONS
Management
evaluates performance of the Company based on operating segments. Segment performance for its two operating segments is based on segment
contribution. The Company’s reportable segments consist of (i) its commercial stage pharmaceutical business known as ImprimisRx;
and (ii) its start-up operations associated with pharmaceutical drug development business (Pharmaceutical Drug Development). Segment
contribution for the segments represents net revenues less cost of sales, research and development, selling and marketing expenses, and
select general and administrative expenses. The Company does not evaluate the following items at the segment level:
●
Selling,
general and administrative expenses that result from shared infrastructure, including certain expenses associated with legal matters,
public company costs (e.g. investor relations), board of directors and principal executive officers and other like shared expenses.
●
Operating
expenses within selling, general and administrative expenses that result from the impact of corporate initiatives. Corporate initiatives
primarily include integration, restructuring, acquisition and other shared costs.
●
Other
select revenues and operating expenses including R&D expenses, amortization, and asset sales and impairments, net as not all
such information has been accounted for at the segment level, or such information has not been used by all segments.
●
Total
assets including capital expenditures.
The
Company defines segment net revenues as pharmaceutical compounded drug sales, licenses, commissions and other revenue derived from related
agreements.
Cost
of sales within segment contribution includes direct and indirect costs to manufacture formulations and sell products, including active
pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling costs, manufacturing equipment and
tenant improvements depreciation, the write-off of obsolete inventory and other related expenses.
Selling,
general and administrative expenses consist mainly of personnel-related costs, marketing and promotion costs, distribution costs, professional
service costs, insurance, depreciation, facilities costs, transaction costs, and professional services costs which are general in nature
and attributable to the segment.
24
Segment
net revenues, segment operating expenses and segment contribution information consisted of the following for the three and six months
ended June 30, 2021:
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION
For the
Three Months Ended
June 30, 2021
ImprimisRx
Pharmaceutical Drug Development
Total
Net revenues
$ 18,134
$ -
$ 18,134
Cost of sales
( 4,417 )
-
( 4,417 )
Gross profit
13,717
-
13,717
Operating expenses:
Selling, general and administrative
6,422
-
6,422
Research and development
112
104
216
Segment contribution
$ 7,183
$ ( 104 )
7,079
Corporate
2,662
Research and development
209
Amortization
39
Operating income
$ 4,169
For the
Six Months Ended
June 30, 2021
ImprimisRx
Pharmaceutical Drug Development
Total
Net revenues
$ 33,577
$ -
$ 33,577
Cost of sales
( 8,187 )
-
( 8,187 )
Gross profit
25,390
-
25,390
Operating expenses:
Selling, general and administrative
12,193
-
12,193
Research and development
322
117
439
Segment contribution
$ 12,875
$ ( 117 )
12,758
Corporate
5,015
Research and development
578
Amortization
79
Operating income
$ 7,086
For the
Three Months Ended
June 30, 2020
ImprimisRx
Pharmaceutical Drug Development
Total
Net revenues
$ 8,060
$ -
$ 8,060
Cost of sales
( 3,204 )
-
( 3,204 )
Gross profit
4,856
-
4,856
Operating expenses:
Selling, general and administrative
4,598
43
4,641
Research and development
497
46
543
Segment contribution
$ ( 239 )
$ ( 89 )
( 328 )
Corporate
2,270
Research and development
206
Amortization
43
Asset sales and impairments, net
363
Operating loss
$ ( 3,210 )
25
For the
Six Months Ended
June 30, 2020
Pharmaceutical
Pharmaceutical
Compounding
Drug Development
Total
Net revenues
$ 19,877
$ -
$ 19,877
Cost of sales
( 6,830 )
-
( 6,830 )
Gross profit
13,047
-
13,047
Operating expenses:
Selling, general and administrative
11,238
87
11,325
Research and development
540
57
597
Segment contribution
$ 1,269
$ ( 144 )
1,125
Corporate
3,957
Research and development
555
Amortization
88
Asset sales and impairments, net
363
Operating loss
$ ( 3,838 )
The
Company categorizes revenues by geographic area based on selling location. All operations are currently located in the U.S.; therefore,
total revenues are attributed to the U.S. All long-lived assets at June 30, 2021 and December 31, 2020 were located in the U.S.
Concentrations
The
Company has two products that each comprised more than 10% of total revenues during the quarter. These products collectively accounted
for 36 % of revenues during each of the three and six months ended June 30, 2021.
The
Company sells its compounded formulations to a large number of customers. There were no customers who comprised more than 10% of the
Company’s total pharmacy sales for the three and six months ended June 30, 2021 and 2020.
The Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 85 %
and 79 % of active pharmaceutical ingredient purchases during the three and six months ended June 30, 2021, respectively, and 60 % and
70 % of active pharmaceutical ingredient purchases during the three and six months ended June 30, 2020, respectively.
NOTE
17. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to June 30, 2021 through the filing date of this Quarterly Report.
Based on its evaluation, no events other than those described below need to be disclosed.
Sintetica
Agreement
In
July 2021, the Company entered into a License and Supply Agreement (the “Sintetica Agreement”) with Sintetica S.A. (“Sintetica”),
pursuant to which Sintetica granted the Company the exclusive license and marketing rights to its patented ophthalmic drug candidate
(“AMP-100”) in the U.S. and Canada.
Pursuant
to the Sintetica Agreement, the Company will pay Sintetica a per unit transfer price to supply AMP-100, along with a per unit royalty
for units sold. The Company is required to pay Sintetica up to $ 18,000 in one-time milestone payments including a $ 5,000 payment due
within 30 days of signing the Sintetica Agreement and the balance of payments due upon achievement of certain regulatory and commercial
milestones. Under the terms of the Sintetica Agreement, Sintetica will be responsible for regulatory filings for AMP-100 in the U.S.
Subject
to certain limitations, the term of the Sintetica Agreement is ten years, and allows for a ten-year extension if certain sales thresholds
are met.
26
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